New lab removes barrier between research and patient care

Virginia Tech marked a step forward in biomedical innovation in Southwest Virginia with the opening a clean room facility to produce clinical-grade therapies under federally regulated Good Manufacturing Practice (GMP) standards.

The facility at the Fralin Biomedical Research Institute at VTC in Roanoke enables researchers and companies to manufacture clinical-grade materials that meet federal standards required for testing in human and animal patients.

Until now, that capability has been largely unavailable in the region, often forcing companies to look elsewhere to advance their work.

“The clean room facility is a critical step in translating discovery into real-world impact by enabling researchers to move promising therapies from the laboratory into early-stage manufacturing for patient use,” said Michael Friedlander, executive director of the Fralin Biomedical Research Institute at VTC and Virginia Tech vice president for health sciences and technology. “It grew out of real needs identified by academic researchers and companies in the region and reflects a collaborative effort to build the infrastructure required to support them.

“The facility will enable Virginia Tech researchers across all campuses to integrate this critical step into their work as they compete for federal, industry, and private funding to advance early stage discoveries toward applications and treatments,” Friedlander said. “Moreover, it will provide a major attractor for biotechnology businesses including those already located in our region as well as those from outside the area considering locating their operations here to facilitate their later stage discovery to production and market pipeline.” 

A clean room is a sealed, highly controlled space with smooth, non-porous walls and a constant flow of filtered air. Air pressure inside the room is higher than adjacent areas, so when a door opens, air flows outward, preventing contaminants from entering.

A key feature is the facility’s ability to support GMP standards, established and enforced by the U.S. Food and Drug Administration, for producing clinical-grade materials used in human and animal studies.

Webster Santos, director of the Virginia Tech Center for Drug Discovery and a professor in the College of Science, said GMP standards are crucial to advance therapies to patients.

“GMP standards ensure everything produced follows rigorous, documented protocols and can be safely used in humans,” Santos said. “To enter Phase I clinical trials, the FDA requires that compounds be manufactured under GMP conditions, making facilities like this essential for advancing research toward clinical use.”

For researchers working to translate discoveries into treatments, and for patients urgently waiting for new therapies, GMP standards define what is possible beyond the laboratory. 

“We are developing gene therapies for diseases such as pulmonary fibrosis and pulmonary hypertension, where there are currently no cures,” said Yassine Sassi, an assistant professor at the Fralin Biomedical Research Institute who plans to use the clean room for his research program. “We’ve seen strong results in cells and animal models, but to move into clinical trials for human or companion animal patients, these therapies must be produced under GMP conditions. Facilities like this are essential for taking that next step.”

Rob Gourdie, a professor at the Fralin Biomedical Research Institute, helped identify the need for precision clean-room capabilities while developing drug delivery technologies based on exosomes — naturally occurring nanoparticles derived from cow’s milk that can be used to transport therapeutic compounds within the body.

The research led Gourdie and collaborators to start the Roanoke-based biotechnology company Tiny Cargo. Recently, the company established its own larger scale commercial clean room to support early-stage manufacturing.

“It’s one thing to make a discovery in the laboratory but translating that work into therapies that can actually be used in patients requires facilities like this,” Gourdie said. “Without them, promising ideas often fail to advance to clinical testing.”

Spencer Marsh, who co-founded Tiny Cargo with Rob Gourdie, traveled to New Zealand in the summer of 2023 to support early manufacturing efforts and help guide production.

As the team worked to scale their technology, they encountered a lack of available clean room space in the Southwest Virginia. In conversations with executives at other startups, Marsh found the challenge was widespread.

Some companies were considering relocating to established biotech hubs such as North Carolina’s Research Triangle, while others were exploring outsourcing manufacturing.

That experience helped spark broader discussions at Virginia Tech and the Fralin Biomedical Research Institute about how to address the gap. The institute ultimately led the development of a GO Virginia Region 2 proposal focused on assessing demand in the area and piloting shared clean room infrastructure.

“One of the biggest barriers for startups and researchers in this region has been access to GMP manufacturing space,” Marsh said. “This clean room removes that barrier and reflects a broader, collaborative effort to build the infrastructure needed to support companies and innovation in this region.”

The facility was developed through a collaborative effort among Virginia Tech and a broad network of regional partners, including GO Virginia, the Red Gates Foundation, local governments, and economic development organizations. This collective investment reflects a shared commitment to expanding biomanufacturing capacity and accelerating innovation in Southwest Virginia, officials said.

Now that it is operational, the facility is expected to be used by Virginia Tech researchers, startup companies, and biotechnology firms across Southwest Virginia.

In addition to accelerating research translation, it will provide hands-on training opportunities for students and trainees, strengthening the region’s biotechnology workforce.